Project Engineer

Flexible & Integrated Technical Services, LLC•Añasco, PR

20d

About The Position

The Project Engineer leads and executes labeling update projects in the Project Engineering area, ensuring timely implementation and compliance with applicable regulatory and quality requirements. The role manages labeling-related change controls from initiation through closure, coordinating implementation planning, documentation updates, verification, stakeholder communication, and effectiveness checks. The position coordinates with cross-functional teams and authors, reviews, and executes validation documentation and qualification activities for labeling equipment, printing systems, software, materials, and related processes as required. It also supports labeling process assessments, issue resolution, project scheduling, continuous improvement, and compliant project documentation.

Requirements

Bachelor’s degree in Engineering.
At least five years of experience in validation, labeling, quality, manufacturing, or other regulated industry environments.
Bilingual in Spanish and English.
Experience leading labeling update projects and managing change controls through implementation.
Experience executing validation activities, including protocol development and qualification documentation.
Working knowledge of FDA QSR, ISO 13485, GMP requirements, and regulated manufacturing practices.
Experience using Microsoft Project and PLM/ERP systems.
Experience collaborating with cross-functional teams to deliver projects.

Responsibilities

Lead and execute labeling update projects, ensuring timely implementation and compliance with regulatory and quality requirements.
Manage labeling-related change control activities from initiation through closure, including implementation planning, documentation updates, verification, stakeholder communication, and effectiveness checks.
Coordinate cross-functional activities with Quality, Regulatory Affairs, Operations, Manufacturing, Supply Chain, Product Development, Engineering, and IT teams.
Author, review, and execute validation documentation, including validation plans, protocols, test scripts, reports, risk assessments, and impact assessments, as required.
Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for labeling equipment, printing systems, software, and related processes, when required.
Support qualification and implementation of new label materials, printers, barcode systems, vision systems, and labeling software, when required.
Investigate and resolve issues encountered during labeling updates, validation activities, or implementation efforts.
Assess existing labeling processes and documentation as required; identify risks, gaps, and compliance concerns; and recommend corrective or preventive actions.
Develop, maintain, and monitor project schedules using Microsoft Project and provide regular status updates to stakeholders, as required.
Drive continuous improvement initiatives focused on labeling processes, project execution, compliance, and operational efficiency.
Ensure project documentation complies with company procedures, GMP requirements, quality system standards, and data integrity expectations.
Use Microsoft Office applications for project planning, reporting, documentation, data analysis, and presentations.